A Study of Entresto in Tetralogy of Fallot (TOF) and Ebstein’s Anomaly (EA)

Overview

About this study

The purpose of this study is to compare changes in RV structure and function, biomarkers, and patient reported outcomes between TOF patients randomized to an ARNI vs placebo.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • TOF or EA
  • Age 18 or Older

​​​​​​​​​​​​​​Exclusion Criteria:

  • Stage IV chronic kidney disease defined as creatinine clearance <30 ml/min
  • Hyperkalemia defined as serum potassium >5.2 mmol/l,
  • Hypotension defined as systolic blood pressure <100 mmHg,
  • History of angioedema related to previous ACE or ARB therapy
  • Patients diagnosed with diabetes using Aliskiren,
  • Pregnancy.
  • Drug Therapies
    • Amifostine
    • Droperidol
    • Dantrolene
    • CYP3A4 Inhibitors
    • Obinutuzumab
    • Simvastatin >20mg
    • Aliskiren
    • Lithium
    • Sparsentan
    • ACE inhibitor
    • ARB
    • ARNI

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 08/23/2024. Questions regarding updates should be directed to the study team contact.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Alexander Egbe, M.B.B.S., M.P.H.

Contact us for the latest status

Contact information:

Adult Congenital Research Program

(507) 293-2565

RSTACHDRESPRG@mayo.edu

More information

Publications

Publications are currently not available